Healthy people who contribute DNA samples for medical research see their relationship with researchers more as a license for sharing a trade secret than participation in traditional medical research, say UNC School of Law researchers John Conley, William Rand Kenan Jr. Professor of Law; Arlene Davis, adjunct professor of law and associate professor of social medicine at UNC School of Medicine; alumna Allison Dobson '09; and second-year law student Ryan Gladden, Conley's research assistant. The team studied interviews with research participants and discovered that even though they had read informed consent documents which explicitly stated that their contribution of DNA was not a commercial transaction, subjects still perceived the exchange in that light.
"If you listen to what DNA sample contributors - research subjects - say about their participation, they understand it more than anything else as a commercial transaction," explains Conley, who says the policy paper titled "Genomics, Biobanks, and the Trade-Secret Model," published in Science on April 15, is intended to start a debate about the nature of informed consent in DNA-related research. Traditionally, informed consent for the purposes of medical research tries to make it explicitly clear that research subjects are not entering into a commercial exchange that would in some way reward their participation.
"Why not do it differently for DNA research? DNA contributed by healthy donors is quite different from giving a liver, for example," observes Conley.
People who were interviewed about their views on research using contributed DNA expressed a range of views. About half of those interviewed had contributed, while the other half had been asked to contribute but declined.
"Some said 'just give me the money and I'm done.' Others would have taken less money but with conditions such as being able to opt out of a future research project or being told if researchers find something that has a bearing on their personal health," says Conley, who argues in favor of a tiered consent which would give people more or less control over the use of their DNA depending on their preferences.
Conley says that using trade secrets as a paradigm for the contribution of DNA to research would solve several current problems. One of them is how to handle DNA and tissues stored in banks for the purposes of research. Getting informed consent from donors for each new research application is burdensome, says Conley; with a trade secret approach, however, individuals could give blanket consent or could retain the right to opt out of future research programs.
"We are trying to fit old models onto new technologies, such as biobanking," observes co-author Gladden, Conley's research assistant. "This is one solution."
Conley, Gladden and Dobson collaborated with co-authors Robert Mitchell from Duke University's Institute for Genome Sciences and Policy, and R. Jean Cadigan from UNC's Department of Social Medicine. All of the authors are also affiliated with the UNC Center for Genomics and Society.
Editor's note: See responses from the research community and further comments from the original authors in
Science, Sept. 16, 2011
-April 15, 2011